A Phase III, Multicenter, Randomized, Double-Blind Clinical Trial to Assess the Efficacy and Safety of SVT-15652 Otic Solution Compared to Placebo for the Treatment of Fungal Otitis Externa (Otomycosis).

Salvat1 site in 1 country194 target enrollmentJune 9, 2020

ConditionsOtomycosis

InterventionsSVT-15652 Placebo

DrugsSVT-15652 Placebo

Overview

Phase: Phase 3
Intervention: SVT-15652
Conditions: Otomycosis
Sponsor: Salvat
Enrollment: 194
Locations: 1
Primary Endpoint: Therapeutic Cure (Clinical and Mycological Cure)
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

Multicenter, randomized, 2-arm parallel-group, double blind, placebo-controlled study in patients suffering from Otomycosis. This study will compare the efficacy and safety of SVT-15652 otic solution to that of Placebo, when administering one vial twice daily during 14 days.

Registry

clinicaltrials.gov

Start Date

June 9, 2020

End Date

October 19, 2021

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Salvat

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•At least 18 years of age
•Clinical diagnosis of otomycosis in one or both ears, where topical treatment is indicated.
•Signs/symptoms of pruritus, otalgia and ear fullness.
•Debris or drainage clinically consistent with fungal infection.

Exclusion Criteria

•Known bacterial otitis externa or malignant otitis externa.
•Tympanic perforation, tympanostomy tubes inserted and post mastoid surgery.
•Structural ear anomalies which may difficult the evaluation of the therapeutic response.
•Uncontrolled diabetes mellitus.
•Any infection requiring systemic antimicrobial or systemic antifungal therapy.
•Concomitant medicines that may interfere with the study evaluations.